Clinical TrialApr 27, 2026, 09:17 AM
MANE VDPHL01 Phase 2/3 Trial Positive: Hair Growth +30.3-33.0 hairs/cm²
AI Summary
Veradermics announced positive topline data from its Phase 2/3 clinical trial (Study '302') for VDPHL01, an oral minoxidil formulation, in males with mild-to-moderate pattern hair loss. The trial met all primary and key secondary endpoints with high statistical significance, demonstrating rapid, robust hair growth and a favorable safety profile. VDPHL01 achieved a mean increase in non-vellus target area hair count of 30.3 hairs/cm² (once daily) and 33.0 hairs/cm² (twice daily) versus 7.3 hairs/cm² for placebo at Month 6. The company believes VDPHL01 has the potential to become the first FDA-approved non-hormonal oral treatment for pattern hair loss in nearly 30 years.
Key Highlights
- Veradermics' VDPHL01 Phase 2/3 trial (Study '302') met all primary and key secondary endpoints with high statistical significance (p<0.0001).
- Mean increase in non-vellus TAHC was 30.3 hairs/cm² (QD) and 33.0 hairs/cm² (BID) versus 7.3 hairs/cm² for placebo at Month 6.
- Approximately 79.3% (QD) and 86.0% (BID) of patients reported any improvement in PRO versus 35.6% of placebo patients.
- 48.4% (QD) and 62.9% (BID) of patients reported 'improved' or 'much improved' outcomes at Month 6 versus 13.4% of placebo patients.
- Statistically significant improvement in hair growth was observed at Month 2, the earliest time point evaluated.
- VDPHL01 demonstrated a favorable safety and tolerability profile with overall adverse event rates similar to placebo and no treatment-related SAEs.
- Study '302' enrolled 519 patients.
- Topline results for the second Phase 3 male trial (Study '304') are anticipated in the second half of 2026.